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ASTM E 2968 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
Available format(s)

Hardcopy , PDF

Superseded date

08-17-2023

Language(s)

English

Published date

04-13-2015

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 14.02, 2016 Defines key concepts and principles to assist in the appropriate selection, development and operation of continuous processing technologies for the manufacture of pharmaceutical products.

1.1This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of continuous processing technologies for the manufacture of pharmaceutical products.

1.2Particular consideration is given to the development and application of the appropriate scientific understanding and engineering principles that differentiate continuous manufacture from traditional batch manufacturing.

1.3Most of the underlying concepts and principles (for example, process dynamics and process control) outlined in this guide can be applied in both Drug Substance (DS) and Drug Product (DP) processes. However it should be recognized that in Drug Substance production the emphasis may be more on chemical behavior and dynamics in a fluid phase whereas for drug product manufacture there may be a greater emphasis on the physical behavior and dynamics in a solid/powder format.

1.4This guide is also intended to apply in both the development of a new process, or the improvement/redesign of an existing one.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Committee
E 55
DocumentType
Guide
Pages
15
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM E 3326 : 2022 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

ASTM E 2363 : 2005 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2898 : 2020 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2363 : 2005 : REV B Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2898 : 2013 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2898 : 2014 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2537 : 2016 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
ASTM E 2363 : 2004 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2006 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2537 : 2008 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
ASTM E 2475 : 2010 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
ASTM E 2363 : 2004 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2898 : 2014 : REDLINE Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2475 : 2010 : R2016 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
ASTM E 2363 : 2005 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2006 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2537 : 2016 : REDLINE Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

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Hardcopy - English
PDF - English
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